{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations on accreditation of third-party certification bodies to conduct food safety audits and to issue certifications to provide for a reimbursement (user fee) program to assess fees for the work FDA performs to establish and administer the third-party certification program under the FDA Food Safety Modernization Act (FSMA).","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2016/12/14/2016-30033.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1,"title":21}],"citation":"81 FR 90186","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective January 13, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0146"],"dockets":[],"document_number":"2016-30033","effective_on":"2017-01-13","end_page":90194,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/12/14/2016-30033.xml","html_url":"https://www.federalregister.gov/documents/2016/12/14/2016-30033/amendments-to-accreditation-of-third-party-certification-bodies-to-conduct-food-safety-audits-and-to","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-30033?publication_date=2016-12-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-12-14/2016-30033/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":6187,"last_updated":"2026-10-25 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-12-14/pdf/2016-30033.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-30033.pdf?1481636773","publication_date":"2016-12-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/12/14/2016-30033.txt","regulation_id_number_info":{"0910-AH23":{"issue":"201610","html_url":"https://www.federalregister.gov/regulations/0910-AH23/user-fees-for-fda-s-third-party-accreditation-program-for-food-and-feed","title":"User Fees for FDA's Third-Party Accreditation Program for Food and Feed","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201610&RIN=0910-AH23&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AH23"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 03 Regulatory Impact Analysis for Third-Party Final Rule re Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications to Provide for User Fee Program","document_id":"FDA-2011-N-0146-0245"},{"title":"Reference 02 Preliminary Regulatory Impact Analysis for Third-Party Proposed Rule re Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications to Provide for User Fee Program","document_id":"FDA-2011-N-0146-0244"},{"title":"Reference 01 ISO IEC 17011-2004_copyright re Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications to Provide for User Fee Program","document_id":"FDA-2011-N-0146-0243"},{"title":"List of References re Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications to Provide for User Fee Program","document_id":"FDA-2011-N-0146-0242"},{"title":"Reference 25: FDA, “Tribal Summary Impact Statement: Final Rule on Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue,” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Iss","document_id":"FDA-2011-N-0146-0218"},{"title":"Reference 24: International Organization for Standardization, “ISO/TS 22003:2013 Food Safety Management Systems--Requirements for Bodies Providing Audit and Certification of Food Safety Management Systems,” re Accreditation of Third-Party Certification Bo","document_id":"FDA-2011-N-0146-0217"},{"title":"Reference 23: Safe Quality Food Institute, “SQF Code, Edition 7.2: A HACCP-Based Supplier Assurance Code for the Food Industry,” July 2014 re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications","document_id":"FDA-2011-N-0146-0216"},{"title":"Reference 21: International Organization for Standardization/International Electrotechnical Commission, “ISO 22000:2005 Food Safety Management Systems--Requirements for Any Organization in the Food Chain,” re Accreditation of Third-Party Certification Bod","document_id":"FDA-2011-N-0146-0215"},{"title":"Reference 19: Danish Accreditation Fund, “DANAK Home” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications","document_id":"FDA-2011-N-0146-0214"},{"title":"Reference 18: United Kingdom Accreditation Service, “About UKAS,” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications","document_id":"FDA-2011-N-0146-0213"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AG66/accreditation-of-third-party-auditors-certification-bodies-to-conduct-food-safety-audits-and-to-issu","title":"Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications\n"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2011-N-0146","supporting_documents_count":29,"docket_id":"FDA-2011-N-0146","regulation_id_number":"0910-AG66","title":"Accreditation of Third-Party Auditors","checked_regulationsdotgov_at":"2017-01-03T06:00:21Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":90186,"subtype":null,"title":"Amendments to Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications To Provide for the User Fee Program","toc_doc":"Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications to Provide for User Fee Program","toc_subject":null,"topics":["Cosmetics","Drugs","Exports","Food labeling","Imports","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":81}